Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

NCT00320983 | Completed Phase 1 DMC

• 1 other identifier: 1601C
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Conditions

Cervical Cancer

Keywords

Cancer; Cervix

Outcome Measures

Primary Outcomes (1)

• disease progression

  disease progress or complete remission

Interventions

Topotecan DRUG

Topotecan

Also known as: Hycamtin

Cisplatin DRUG

Cisplatin

Also known as: Platinol AQ

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one of the following risk factors:
• Primary tumor \> 6 cm
• Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
• Positive surgical margins
• Depth of invasion greater than 50 % and positive capillary-lymphatic space involvement
• Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix

You may not qualify if:

• Patients with GOG performance status of 0, 1, or 2.
• Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection.
• Patients must have adequate:
• Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3.
• Renal function: Creatinine less than or equal to 2.0 mg/dl.
• Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal.
• Patients must have signed an approved informed consent.
• Patients have met the pre-entry requirements specified in Section 7.0
• Patients with GOG performance of 3 or 4.
• Patients with another malignancy, prior or concomitant, other than skin (excluding melanoma).
• Patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction.
• Patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.).
• Patient with recurrent cervical cancer
• Patients who have received prior pelvic radiation
• Pregnant women and women of childbearing potential not using an effective form of contraception.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Topotecan; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Harriet Smith, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: March 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: December 1, 2005
• Last Updated: January 7, 2010

Record last verified: 2008-10

Locations

US (1)